Smart Path OMNI Thread Fixture

GUDID 08800076444157

Truabutment Korea Co.,Ltd

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800076444157
• NIH Device Record Key: 0a9cb71e-9fcc-4bd8-938e-ec0b5aa744a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Path OMNI Thread Fixture
• Version Model Number: SPOT40130
• Company DUNS: 694514760
• Company Name: Truabutment Korea Co.,Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800076444157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230438

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-03
• Device Publish Date: 2026-01-26

On-Brand Devices [Smart Path OMNI Thread Fixture]

• 08800076444409: SPOT65100
• 08800076444393: SPOT65085
• 08800076444386: SPOT65070
• 08800076444379: SPOT60100
• 08800076444362: SPOT60085
• 08800076444355: SPOT60070
• 08800076444348: SPOT55145
• 08800076444331: SPOT55130
• 08800076444324: SPOT55115
• 08800076444317: SPOT55100
• 08800076444300: SPOT55085
• 08800076444294: SPOT55070
• 08800076444287: SPOT50145
• 08800076444270: SPOT50130
• 08800076444263: SPOT50115
• 08800076444256: SPOT50100
• 08800076444249: SPOT50085
• 08800076444232: SPOT50070
• 08800076444225: SPOT45145
• 08800076444218: SPOT45130
• 08800076444201: SPOT45115
• 08800076444195: SPOT45100
• 08800076444188: SPOT45085
• 08800076444171: SPOT45070
• 08800076444164: SPOT40145
• 08800076444157: SPOT40130
• 08800076444140: SPOT40115
• 08800076444133: SPOT40100
• 08800076444126: SPOT40085
• 08800076444119: SPOT40070
• 08800076444102: SPOT35145
• 08800076444096: SPOT35130
• 08800076444089: SPOT35115
• 08800076444072: SPOT35100
• 08800076444065: SPOT35085